Prophylactic Mesh Reinforcement for Stoma Closure

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain; Incisional Hernia; Surgical Site Infection
• Interventions: Device: Prolene mesh

• Registration Number: NCT06157645
• Lead Sponsor: Assiut University

Brief Summary

n the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay

Detailed Description

Intestinal stomas are used to divert intestinal content as a treatment option. Faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. A stoma may be temporary or permanent according to the condition. Temporary stomas are usually followed by elective stoma closure 6-8 weeks after. Though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications.

Incisional hernia following stoma closure occurs in up to 30% of patients. Incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. Other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. Mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (SSIH) with low complications risk. Though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use Mesh-reinforced stoma closure.

In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (SSIH),incidence of surgical site infection ,post-operative Pain and Hospital stay

Study Timeline

• Study First Submitted: 2023-11-26
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Start: 2024-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients who are fit for aesthesia.
• Patients with temporary double barrelled and simple loop ostomy
• Patients older than 16 years old

Exclusion criteria:

• Patients with end ostomy
• Infected stomas

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Prolene mesh	1. Good preparation of the patient preoperative 2. Performing an opening in the skin surrounding the stoma 3-4 mm from the muco-cutaneous junctions. 3. Separate the bowel loop away from its attachment to the abdomen wall. 4. Cut out a rim of 0.3-0.4 cm of scarred bowel edges exposes healthful tissue. 5. Avoid any spillage or soiling 6. Closing of bowel defect can be made by double layer of 3-0 vicryl interrupted. 7. Once the tissue is of poor quality for simply closing, we expand the incision in the abdomen wall and resect a section. An end-to-end anastomosis is created using the conventional 2-layers suture method. 8. Reduction of the bowel into the abdomen are carried out. 9. irrigation the surgical field with a dilute anti-biotics or antiseptics and closure of the defect by continuous sutures using vicryl or prolene sutures 10. mesh is simply fixed over the defect as a tension-free patch (onlay) 11. Closure of the wound

Primary Outcome Measures

Name	Time	Method
the risk of developing surgical site incisional hernia (SSIH)	through study completion, an average of 1 year	Compare between the incidence of surgical site incisional hernia in group a and group b

Secondary Outcome Measures

Name	Time	Method
surgical site infection	Up to 12 weeks	Compare between the incidence of surgical site infection in group a and group b
post-operative Pain	immediately after the intervention	Compare between the incidence of post operative pain in group a and group b using numeric pain rating scale from 0 to 10
Hospital stay	through study completion, an average of 1 year	Compare between the lenght of hospital stay post operative in group a and group b